Compositions comprising flavonoids and tocotrienols and methods thereof

Abstract

Disclosed in certain embodiments is a pharmaceutical formulation comprising a pharmaceutical ingredient comprising an active agent combination comprising flavonoids and tocotrienols in a ratio of about 75:25 to about 95:5 and at least one pharmaceutically acceptable excipient.

1 . A pharmaceutical ingredient comprising an active agent combination comprising polymethoxylated flavonoids and tocotrienols in a ratio of about 75:25 to about 95:5, the pharmaceutical composition selected from the group consisting of an essence oil isolated from a  citrus  fruit, a peel oil isolated from a  citrus  fruit, a peel isolated from a  citrus  fruit, decharacterized  citrus  fruit, and combinations thereof.  
   
   
       2 . The pharmaceutical ingredient according to  claim 1 , wherein the active agent combination comprises flavonoids and tocotrienols in a ratio of about 90:10.  
   
   
       3 . The pharmaceutical ingredient according to  claim 1 , wherein the active agent combination comprises flavonoids and tocotrienols in a ratio of about 80:20.  
   
   
       4 . The pharmaceutical ingredient according to  claim 1 , wherein the active agent combination comprises flavonoids and tocotrienols in a ratio of about 95:5.  
   
   
       5 . The pharmaceutical ingredient according to  claim 1 , comprising from about 50% to about 90% of the active agent combination.  
   
   
       6 . The pharmaceutical ingredient according to  claim 1 , comprising from about 60% to about 80% of the active agent combination.  
   
   
       7 . The pharmaceutical ingredient according to  claim 1 , comprising from about 70% of the active agent combination.  
   
   
       8 . The pharmaceutical ingredient according to  claim 1 , wherein the flavonoid comprises a member consisting of naringenin, hesperetin, nobiletin, and tangeretin.  
   
   
       9 . The pharmaceutical ingredient according to  claim 1 , wherein the tocotrienol is selected from the group consisting of alpha-tocotrienol, gamma-tocotrienol, and delta-tocotrienol.  
   
   
       10 . A pharmaceutical formulation comprising a pharmaceutical ingredient comprising an active agent combination comprising flavonoids and tocotrienols in a ratio of about 75:25 to about 95:5 and at least one pharmaceutically acceptable excipient.  
   
   
       11 - 20 . (canceled)  
   
   
       21 . The pharmaceutical formulation according to  claim 10 , wherein the formulation lowers total cholesterol by at least 10%.  
   
   
       22 . The pharmaceutical formulation according to  claim 21 , wherein the formulation lowers total cholesterol by at least 10% in a single patient.  
   
   
       23 . The pharmaceutical formulation according to  claim 21 , wherein the formulation lowers total cholesterol by at least 10% in a patient population  
   
   
       24 - 29 . (canceled)  
   
   
       30 . The pharmaceutical formulation according to  claim 10 , wherein the formulation lowers triacylglycerols by at least 15%.  
   
   
       31 . The pharmaceutical formulation according to  claim 30 , wherein the formulation lowers triacylglycerols by at least 15% in a single patient.  
   
   
       32 . The pharmaceutical formulation according to  claim 30 , wherein the formulation lowers triacylglycerols by at least 15% in a patient population  
   
   
       33 - 38 . (canceled)  
   
   
       39 . The pharmaceutical formulation according to  claim 10 , wherein the formulation lowers LDL cholesterol by at least 10%.  
   
   
       40 . The pharmaceutical formulation according to  claim 39 , wherein the formulation lowers LDL cholesterol by at least 10% in a single patient.  
   
   
       41 . The pharmaceutical formulation according to  claim 39 , wherein the formulation lowers LDL cholesterol by at least 10% in a patient population  
   
   
       42 - 47 . (canceled)  
   
   
       48 . The pharmaceutical formulation according to  claim 10 , wherein the formulation lowers Apo B by at least 10%.  
   
   
       49 . The pharmaceutical formulation according to  claim 48 , wherein the formulation lowers Apo B by at least 10% in a single patient.  
   
   
       50 . The pharmaceutical formulation according to  claim 48 , wherein the formulation lowers Apo B by at least 10% in a patient population.  
   
   
       51 - 56 . (canceled)  
   
   
       57 . A pharmaceutical formulation comprising a pharmaceutical ingredient comprising an active agent combination comprising flavonoids and tocotrienols and an additional active agent selected from the group consisting of soy protein, soy isoflavones, grapeseed extract, pine bark extract, gugulipids, policosinols, pantesine, niacin, alpha lipoic acid, tea flavins, coenzyme q10, lutein, statins, and combimations thereof.  
   
   
       58 - 60 . (canceled)  
   
   
       61 . A method of treating a human subject at risk of or suffering from cardiovascular disease comprising administering an effective amount of a pharmaceutical formulation according to  claim 10 .  
   
   
       62 . The method of  claim 61 , wherein the cardiovascular disease is hypercholesterolemia or atherosclerosis.  
   
   
       63 - 77 . (canceled)  
   
   
       78 . A pharmaceutical formulation comprising a pharmaceutical ingredient comprising an active agent combination comprising flavonoids and tocotrienols and at least one pharmaceutically acceptable excipient, the formulation lowering total cholesterol by at least 10% after administration.  
   
   
       79 - 85 . (canceled)